Kornimate/medical-research-clean huggingface dataset:
effect of olorinab on gastrointestinal transit in patients with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: a phase 1b study to determine the effect of oral olorinab on gastrointestinal transit in adult participants with irritable bowel syndrome (ibs).

this is a single-center, randomized, crossover, double-blind, placebo-controlled study designed to evaluate the effects of olorinab on gastric, small-bowel, and colonic transit in ibs participants with predominant constipation (ibs-c) or with predominant diarrhea (ibs-d).

Eligibility criteria:
inclusion criteria: * diagnosis of irritable bowel syndrome (ibs) with predominant constipation (ibs-c) or ibs with predominant diarrhea (ibs-d) according to rome iv criteria at screening * body mass index (bmi) 18.0 to 40.0 kilograms per square meter (kg/m\^2), inclusive at screening * negative test results for alcohol and selected drugs at screening and day 1 * negative hepatitis panel (including hepatitis b surface antigen \[hbsag\] and hepatitis c virus antibody \[anti-hcv\]) and negative for human immunodeficiency virus (hiv) antibody screens at screening * participants with recent (within 6 months of screening) or ongoing alarm features (unexplained weight loss, nocturnal symptoms, blood mixed with stool) are to have had a diagnostic colonoscopy prior to screening and after the onset of alarm features (for participants with alarm features) to exclude non-ibs conditions per the rome iv diagnostic algorithm for ibs exclusion criteria: * pregnant or lactating * structural or metabolic diseases/conditions that affect the gastrointestinal system * diagnosis of ibs with mixed bowel habits (ibs-m) or unsubtyped ibs (ibs-u) * unable to withdraw medications that alter gastrointestinal (gi) transit for 72 hours prior to baseline colonic transit assay through the duration of treatment period, with the exception of rescue medicine usage (bisacodyl and loperamide) * clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to screening and for the duration of the study that may confound efficacy assessments in the clinical judgment of the investigator (or designee)

Keywords: olorinab apd371 irritable bowel syndrome ibs ibs with predominant constipation ibs-c ibs with predominant diarrhea ibs-d
salty life 7 study: effect of high salt intake on several physiological systems in immobilisation

Conditions: Bone Metabolism; Electrolyte Metabolism; Acid-Base Metabolism; Energy Metabolism; Circulation System

Summary: the salty life 7 study aimed to examine the effect of a high salt (sodium chloride, nacl) intake on different forms of sodium retention, acid-base balance and bone metabolism and other influenced physiological systems. because of the fact that astronauts are a vulnerable group in this context, they were of special interest. astronauts have a high salt intake, probably because of a reduced sense of taste, as well as an increased bone resorption resulting from the lowered mechanical load in space. in which forms sodium could be retained even without fluid retention (osmotically inactive)- contrary to the argumentation of physiological text books - and if the acid-base balance is connected to sodium chloride induced bone loss is examined in a stationary bed rest study with 8 healthy, young, male test subjects. the study consisting of 2 x 21 days is carried out at the german aerospace center (dlr). after an adaptation period of 4 days, test subjects are immobilised in 6° head-down tilt bed rest (simulation model for some physiological changes in space) for 14 days during which they received a high (7.7 mmol nacl/kgbw/d) and a low salt (0.7 mmol nacl/kgbw/d) intake in cross-over design. the form of sodium retention is investigated by the calculation of daily metabolic sodium-, water- and potassium balances and by changes in body weight. the measurements of bone formation (bap, pinp, osteocalcin) markers as well as bone resorption markers (ctx, ntx) supply insight into the influences of a high salt intake on bone metabolism. blood gas analysis and ph values of 24-h urine are used to gather information about accompanying changes in the acid-base balance. further physiological systems like energy metabolism and circulation system are also under investigation.


Eligibility criteria:
inclusion criteria: * male * age: 20-35 years * weight: 65±85kg * height:180±10cm. * successfully completed medical \& psychological screening exclusion criteria: * drugs- and alcohol abuse * hyperlipidemia * obesity * renal diseases * participant of another study in the same time frame and 3 months before starting the study * blood donation within the last three months before starting the study * risk for thrombosis * smoking * diabetes * rheumatism * bone fracture

Keywords: bone metabolism salt intake acid base balance bed rest
phase iii controlled clinical study of npo-11 in patients undergoing gastric endoscopy

Conditions: Patients Undergoing Gastric Endoscopy

Summary: patients who require gastric endoscopy will receive an intragastric single dose of npo-11 20 ml. the superiority of npo-11 to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on the percentage of patients having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy (primary outcome measure). the safety of npo-11 will be evaluated based on adverse events and adverse drug reactions (adrs) observed between administration and seven days after administration in comparison with the placebo group.


Eligibility criteria:
inclusion criteria: inpatients or outpatients of either sex who visit medical institutions for treatment or follow-up of confirmed or suspected upper gastrointestinal disease (symptoms) and meet the criteria (1) and (2) below will be enrolled in the study. patients have to provide written informed consent for voluntary participation in the study. 1. patients who need gastric endoscopy (except for endoscopy with a scope of \<9 mm in diameter, emergency endoscopy and endoscopy for comprehensive medical examination) 2. patients who are older than 20 years at the time of consent exclusion criteria: patients who meet any of the following criteria will be excluded from the study. the criteria (2) to (5) will be confirmed during endoscopy. patients who meet any of these criteria will be withdrawn from the study at the time of confirmation. 1. patients with a history of surgery to the upper gastrointestinal tract 2. patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult 3. patients with upper gastrointestinal bleeding which requires hemostasis 4. patients with reflux esophagitis (los angeles classification: b, c or d) 5. patients with gastric or duodenal ulcers in active stage 6. patients on cancer treatment (chemotherapy or radiotherapy) 7. patients with impaired cardiac function (nyha functional classification: iii or iv) 8. patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil) 9. patients with a history of shock or hypersensitivity to lidocaine hydrochloride 10. pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study 11. patients who have been exposed to npo-11 12. patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies 13. patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion

Keywords: stomach diseases
expression of mcm5 in urine in patients with urothelial cancers

Conditions: Bladder Cancer

Summary: in patients with non-muscle-invasive bladder cancer, the development and introduction to the clinical practice of an adequately accurate biomarker may allow to limit the indications for performing control cystoscopy. thus, it will reduce the discomfort and stress of patients, the risk of complications of the invasive procedure and probably significantly reduce the costs incurred by healthcare systems. the aim of the present study is to determine the usefulness of the determination of mcm5 protein expression in the urine of patients with urinary bladder or upper urinary tract cancer.


Eligibility criteria:
inclusion criteria: * age \>18 years, * written consent to participate in the study, * ability to void and collect \>50ml of urine, * recurrent bladder cancer confirmed by cystoscopy (group 1) or upper urinary tract tumor confirmed by imaging studies (group 2) or no history of urological/gynecological cancers (controls) exclusion criteria: * urinary tracy infection, * nephrolithiasis

Keywords: bladder cancer biomarker urothelial cancer cystoscopy
fish oils and soybean lecithin supplementation modulate immune function in runners

Conditions: Immune Dysfunction

Summary: the purpose of this study was evaluate the comparative effects of fo rich in epa (fo-epa) and fo rich in dha (fo-dha) on inflammation and neutrophil properties after a prolonged and strenuous exercise. the effect of soybean lecithin on the same parameters and conditions also was evaluated.

the volunteers were not taking any medication during the study. all individuals signed an informed consent form to the study protocol. both experimental procedure and informed consent form of this study were in accordance with guide for the care and use of humans. all volunteers performed two half-marathons. in the first half-marathon, all participants were not supplemented. dietary supplementation was initiated immediately after the first race. the volunteers were randomly separated into 3 groups: soybean lecithin group; fish oil-dha group and fish oil-epa group. the volunteers ingested 3 g daily of sl or fo-dha containing 1.5 g dha and 0.3 g epa or fo-epa containing 1.6 g epa and 0.3 g dha (epa:dha = 5.4:1) during 60 days. experimental design: first race - not supplemented, blood samples were collected before (phase i) and immediately after race (phase ii). second race - dietary supplemented, blood samples were collected before (phase iii) and immediately after the race (phase iv). results were analyzed by two-way analysis of variance (two-way anova) and tukey post-hoc test. the statistical analysis of the half-marathon effect was performed using nonparametric t tests. results were considered statistically significant for p\<0.05.

Eligibility criteria:
inclusion criteria: healthy recreational half-marathon runners. exclusion criteria: auto-immune disease inflammatory disease cardiorespiratory disease

Keywords: strenuous exercise dietary supplementation immune system leucocyte function inflammation
a real world study evaluating the long-term quality of life of tildrakizumab in adult patients with psoriasis

Conditions: Psoriasis

Summary: this is a phase 4 multicenter, uncontrolled open-label study design. there will be a total of 10 study visits at screening, baseline, week 4, week 8, week 12, week 16, week 28, week 40, week 52 and week 64, with subjects receiving tildrakizumab injections at week 0, week 4, week 16, week 28, week 40, and week 52. the total study duration will be approximately 64 weeks, excluding a screening period.


Eligibility criteria:
inclusion criteria: 1. subjects are non-immunocompromised males or females 18 years of age or older. 2. subjects have ≥3% total body surface area plaque psoriasis. 3. subjects are candidates for phototherapy or systemic therapy. 4. subject must be diagnosed at least 6 months prior to entering the study. 5. females must be surgically sterile, postmenopausal for \>5 years, or using a highly effective form of birth control (\<1% failure rate), for at least 30 days prior to test article exposure, with a negative serum pregnancy test. exclusion criteria: 1. subject is pregnant, lactating, or is planning to become pregnant during the study. 2. subject is younger than 18 years of age. 3. subjects with uncontrolled mental illness or active suicidal ideations based on baseline mental health questionnaire of choice. 4. subject is known, or suspected of being unable to comply with the study protocol, in the opinion of the investigator. 5. subject is currently enrolled in an investigational drug or device study.
doxycycline in treatment of bleeding with depot medroxyprogesterone acetate (dmpa)

Conditions: Uterine Hemorrhage

Summary: this study aims to test the effect of doxycycline in treatment of uterine bleeding during the use of injectable contraception that contains one hormone "progesterone only".


Eligibility criteria:
inclusion criteria: 1. women under dmpa contraception for at least one month. 2. accept to participate in the trial after receiving adequate information about the trial including information that she is a part of randomization comprising the possibility of receiving new treatment for bleeding or inactive ingredients. 3. women's ability to keep an accurate menstrual diary for the study. exclusion criteria: 1. lactating women for the fear of the effect of tetracycline on the breast-fed infant. 2. patients with already diagnosed local gynecological abnormality. 3. women receiving treatment for bleeding within the last one month.
alpha radiation emitters device (dart) for the treatment of cutaneous, mucosal or superficial soft tissue neoplasia.

Conditions: Skin Cancer; Mucosal Neoplasm of Oral Cavity; Soft Tissue Neoplasm

Summary: a unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

this will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (dart) delivered through radioactive seeds inserted into the tumor. this approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. superficial lesions with histopathological confirmation of malignancy will be treated using dart seeds. reduction in tumor size 70 days after dart insertion will be assessed. safety will be assessed by the incidence, severity and frequency of all adverse events (ae).

Eligibility criteria:
inclusion criteria: * subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. * subjects with a tumor size ≤ 7 centimeters in the longest diameter. * measurable disease according to recist v1.1. * subjects over 18 years old. * subjects' ecog performance status scale is \< 2. * subjects' life expectancy is more than 6 months. * platelet count ≥100,000/mm3. * international normalized ratio of prothrombin time ≤1.8. * creatinine ≤1.9 mg/dl. * women of childbearing potential (wocbp) will have evidence of negative pregnancy test. * subjects are willing to sign an informed consent form. exclusion criteria: * subject has a tumor of keratoacanthoma histology. * patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.) * patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids * volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of dart. * high probability of protocol non-compliance (in opinion of investigator). * subjects not willing to sign an informed consent. * women who are pregnant or breastfeeding.

Keywords: squamous cell carcinoma scc skin cancer skin metastasis hnscc carcinoma, squamous cmn basal cell carcinoma superficial sarcoma kaposi sarcoma alpha radiation cutaneous lesion tongue cancer lip cancer
lymphedema prevention through immediate lymphatic reconstruction (lily) trial.

Conditions: Lymphedema

Summary: to learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.

primary objectives - to determine the freedom from lymphedema (ffl) rate at 2 years postoperatively in participants with a diagnosis of ibc undergoing ilr at the time of alnd. secondary objectives * estimate the proportion of participants who have lymphedema that persists at 2 years after ilr surgeries. * determine baseline lymphatic vessel anatomical or functional characteristics associated with increased risk of lymphedema following ilr. * evaluate changes in systemic inflammatory mediators and systemic immune cell function affiliated with lymphedema development.

Eligibility criteria:
inclusion criteria: 1. participants diagnosed with ibc. 2. participants who have been scheduled for ilr/plvb by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer 3. participants willing and able to comply with the study protocol requirements and all study-related visit requirements. 4. female subjects at least 18 years old and capable of providing consent to participate. 5. females of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration and agree to use a medically accepted method of contraception for a period of one month following the study. exclusion criteria: 1. patients known to be pregnant or breast-feeding. 2. patients with known or suspected iodine or icg hypersensitivity. 3. patients unable to remain stationary for one hour. 4. active cellulitis. 5. subjects with a preoperative clinical lymphedema diagnosis. 6. subjects undergoing bilateral alnd. 7. subjects requiring immediate chest wall reconstruction with a pedicled or microvascular flap, or those that have received preoperative radiation therapy. 8. patients with bmi \>45kg/m2.
clinical trial on efficacy of rtms to improve ect in treatment-resistant depression

Conditions: Major Depressive Disorder

Summary: it's a prospective, multicentric, randomized, controlled study concerning 56 patients with treatment-resistant depression (trd). the main objective of this study was to evaluate the efficacy of priming repeated transcranial magnetic stimulation (rtms) sessions before electroconvulsive therapy (ect) for treatment of trd patients. the primary outcome will be the depressive symptoms intensity measured with the hamilton rating scale for depression (hamd-21 items) after 5 ect. the secondary outcome is to evaluate the safety and most particularly the cognitive effects of this association.

included patients are adults, aged between 18 and 70 years, with major depression (hamilton rating scale for depression, hamd ≥ 15). patients don't have any experience concerning repeated transcranial magnetic stimulation (rtms). patients with treatment-resistant depression (trd) were assigned to two treatment groups in addition to their current pharmacotherapy regimen : one group received 5 active-rtms before electroconvulsive therapy (ect) and the other one received sham-rtms before ect. the depressive symptoms and the cognitive functions are evaluated before rtms, after 5 rtms and after 5 ect.

Eligibility criteria:
inclusion criteria: * patients with major depressive disorder (hamd≥15) * level of resistance ≥ 3 (thase and rush) * participants who gave their informed, written consent exclusion criteria: * contraindication of electroconvulsive therapy (ect), repeated transcranial magnetic stimulation (rtms), magnetic resonance imaging (mri), anesthesia * history of epilepsy; severe neurological or systemic disorder that could significantly affect cognition * pregnancy

Keywords: treatment-resistant-depression rtms ect augmentation strategy
pilot study of duloxetine in psychological resilience

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to explore benefits of duloxetine in enhancing psychological resilience and to understand the relevance of inhibiting of both serotonin (5ht) and norepinephrine (ne)to therapeutic responses.

this is an investigator-initiated, single-site study consisting of 8 weeks of open-label, fixed-dose treatment with duloxetine (30mg-60mg/day) in patients with major depressive disorder (mdd).

Eligibility criteria:
inclusion criteria: * ages 18-65 * primary diagnosis of mdd based on diagnostic standard manual(dsm-iv) criteria and assessed by the mini international neuropsychiatric interview * montgomery-asberg depression rating scale (madrs)score of at least 20 on baseline * minimum clinical global impressions of severity (cgs) severity score of 4 * ability to provide written consent form * a negative serum pregnancy test for women of childbearing potential exclusion criteria: * current dsm-iv diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder or cognitive disorder due to a general medical condition * history of substance abuse or dependence within the last 6 months * suicide risk or serious suicide attempt within the last year * clinically significant medical condition or laboratory abnormality * women of childbearing potential who are unwilling to practice an acceptable method of contraception * subjects needing concurrent use of psychotropic medications * history of sensitivity to duloxetine * history of failure to respond to an adequate trial of duloxetine (at least 60mg/day for 4 weeks) * subjects taking monoamine oxidase inhibitors (maois) * subjects with uncontrolled narrow-angle glaucoma

Keywords: depression pharmacotherapy duloxetine